Vinblastine side effects: what 1,941 FDA adverse event reports show
Drug class
Alternative therapy
Label matched
Vinblastine Sulfate (Vinblastine Sulfate)
Who reports
1,941 reports · 96% serious · 274 with death outcome · 41% female
Used for
Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies • Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) • Lymphocytic lymphoma (nod.
What it is
DESCRIPTION: Vinblastine sulfate is the salt of an alkaloid extracted from Vinca rosea Linn., a common flowering herb known as the periwinkle (more properly known as Catharanthus roseus G. Don). Previously, the generic name was vincaleukoblastine, abbreviated VLB. It is a stathmokinetic oncolytic agent.
Boxed warning
Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected.
Causality screen of the 38 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 23 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 170 | 27.8 24.1–32.1ROR 30.4 · χ² 4,368 / p <1e-300 | 27.7 EB05 24.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 97% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 21 | 22.7 14.9–34.8ROR 23.0 · χ² 414 / p 2e-92 | 22.3 EB05 15.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 100% clinician | no trial data cached |
| Acute myeloid leukaemia | 30 | 20.9 14.6–29.8ROR 21.2 · χ² 547 / p 3e-121 | 20.6 EB05 15.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Neutrophil count decreased | 75 | 20.0 16.0–25.0ROR 20.8 · χ² 1,337 / p 4e-293 | 19.9 EB05 16.4 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 12.5 · 96% clinician | no trial data cached |
| Ileus | 20 | 17.6 11.4–27.2ROR 17.8 · χ² 296 / p 1e-66 | 17.1 EB05 11.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | no trial data cached |
| Mucosal inflammation | 41 | 17.0 12.6–23.0ROR 17.4 · χ² 602 / p 3e-133 | 16.8 EB05 12.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Drug toxicity | 19 | 14.9 9.5–23.3ROR 15.0 · χ² 232 / p 1e-52 | 14.2 EB05 9.2 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.3 | no trial data cached |
| Pancytopenia (all blood cells low) | 75 | 14.6 11.7–18.2ROR 15.1 · χ² 935 / p 1e-205 | 14.4 EB05 11.9 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 · 95% clinician | no trial data cached |
| Haematotoxicity | 12 | 14.0 8.0–24.6ROR 14.1 · χ² 132 / p 7e-31 | 12.6 EB05 6.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Neurotoxicity | 21 | 13.1 8.5–20.0ROR 13.2 · χ² 222 / p 2e-50 | 12.4 EB05 8.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Interstitial lung disease | 58 | 13.0 10.1–16.7ROR 13.4 · χ² 630 / p 2e-139 | 12.8 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 96% clinician | no trial data cached |
| Myelodysplastic syndrome | 17 | 12.7 7.9–20.4ROR 12.8 · χ² 172 / p 2e-39 | 11.7 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Brain oedema | 14 | 12.0 7.1–20.2ROR 12.1 · χ² 130 / p 2e-30 | 10.6 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 150 | 12.0 10.3–14.0ROR 12.9 · χ² 1,506 / p <1e-300 | 11.9 EB05 10.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 93% clinician | no trial data cached |
| Hypothyroidism | 32 | 10.9 7.7–15.3ROR 11.0 · χ² 277 / p 2e-62 | 10.3 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Pulmonary fibrosis | 18 | 10.2 6.4–16.1ROR 10.3 · χ² 140 / p 1e-32 | 9.0 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Pneumonitis | 24 | 9.6 6.4–14.3ROR 9.7 · χ² 176 / p 1e-40 | 8.7 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 95% clinician | no trial data cached |
| Ataxia | 10 | 9.1 4.9–16.8ROR 9.1 · χ² 64 / p 6e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Myelosuppression | 28 | 8.9 6.2–12.9ROR 9.0 · χ² 189 / p 3e-43 | 8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 96% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 75 | 8.6 6.9–10.7ROR 8.9 · χ² 496 / p 3e-110 | 8.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 93% clinician | no trial data cached |
| Pericardial effusion | 18 | 8.5 5.3–13.4ROR 8.5 · χ² 111 / p 3e-26 | 7.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 14 | 8.2 4.9–13.8ROR 8.2 · χ² 81 / p 1e-19 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Type 2 diabetes mellitus | 24 | 7.7 5.2–11.4ROR 7.8 · χ² 133 / p 5e-31 | 6.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 100% (drug 41%) · 100% clinician | no trial data cached |
| Septic shock | 30 | 7.5 5.3–10.7ROR 7.6 · χ² 163 / p 1e-37 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 96% clinician | no trial data cached |
| Ischaemic stroke | 12 | 7.3 4.1–12.8ROR 7.3 · χ² 59 / p 9e-15 | 5.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Hypoxia (low oxygen) | 23 | 7.1 4.7–10.6ROR 7.2 · χ² 114 / p 5e-27 | 6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Lymphadenopathy | 23 | 7.0 4.7–10.5ROR 7.1 · χ² 113 / p 1e-26 | 6.3 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Ejection fraction decreased | 10 | 6.9 3.7–12.9ROR 7.0 · χ² 45 / p 9e-12 | 5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.6 | no trial data cached |
| Sepsis (blood infection) | 70 | 6.8 5.4–8.5ROR 7.0 · χ² 341 / p 2e-76 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 95% clinician | no trial data cached |
| Acute respiratory distress syndrome | 11 | 6.7 3.7–12.1ROR 6.8 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Leukopenia (low white blood cells) | 31 | 6.7 4.7–9.5ROR 6.8 · χ² 145 / p 9e-34 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 93% clinician | no trial data cached |
| White blood cell count decreased | 66 | 6.6 5.2–8.3ROR 6.8 · χ² 308 / p 3e-69 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 · 95% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 5.9 3.3–10.3ROR 5.9 · χ² 44 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Bone marrow failure | 11 | 5.8 3.2–10.5ROR 5.8 · χ² 39 / p 2e-10 | 4.8 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Disease progression | 55 | 5.0 3.9–6.5ROR 5.2 · χ² 175 / p 3e-40 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Premature baby | 14 | 5.0 3.0–8.4ROR 5.0 · χ² 41 / p 7e-11 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Visual acuity reduced | 11 | 3.5 2.0–6.4ROR 3.6 · χ² 18 / p 1e-5 | 3.2 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Malignant neoplasm progression | 24 | 2.5 1.7–3.8ROR 2.6 · χ² 21 / p 2e-6 | 2.5 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.6 · 96% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 170 | 27.8 24.1–32.1ROR 30.4 · χ² 4,368 / p <1e-300 | 27.7 EB05 24.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 97% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 150 | 12.0 10.3–14.0ROR 12.9 · χ² 1,506 / p <1e-300 | 11.9 EB05 10.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 93% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 75 | 8.6 6.9–10.7ROR 8.9 · χ² 496 / p 3e-110 | 8.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 93% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 75 | 14.6 11.7–18.2ROR 15.1 · χ² 935 / p 1e-205 | 14.4 EB05 11.9 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 · 95% clinician | no trial data cached |
| Neutrophil count decreased | 75 | 20.0 16.0–25.0ROR 20.8 · χ² 1,337 / p 4e-293 | 19.9 EB05 16.4 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 12.5 · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 70 | 6.8 5.4–8.5ROR 7.0 · χ² 341 / p 2e-76 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 95% clinician | no trial data cached |
| White blood cell count decreased | 66 | 6.6 5.2–8.3ROR 6.8 · χ² 308 / p 3e-69 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 · 95% clinician | no trial data cached |
| Interstitial lung disease | 58 | 13.0 10.1–16.7ROR 13.4 · χ² 630 / p 2e-139 | 12.8 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 96% clinician | no trial data cached |
| Disease progression | 55 | 5.0 3.9–6.5ROR 5.2 · χ² 175 / p 3e-40 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Mucosal inflammation | 41 | 17.0 12.6–23.0ROR 17.4 · χ² 602 / p 3e-133 | 16.8 EB05 12.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Hypothyroidism | 32 | 10.9 7.7–15.3ROR 11.0 · χ² 277 / p 2e-62 | 10.3 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Leukopenia (low white blood cells) | 31 | 6.7 4.7–9.5ROR 6.8 · χ² 145 / p 9e-34 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 93% clinician | no trial data cached |
| Septic shock | 30 | 7.5 5.3–10.7ROR 7.6 · χ² 163 / p 1e-37 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 96% clinician | no trial data cached |
| Acute myeloid leukaemia | 30 | 20.9 14.6–29.8ROR 21.2 · χ² 547 / p 3e-121 | 20.6 EB05 15.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Myelosuppression | 28 | 8.9 6.2–12.9ROR 9.0 · χ² 189 / p 3e-43 | 8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Febrile neutropenia — n=170, PRR 27.8
- Pneumocystis jirovecii pneumonia — n=21, PRR 22.7
- Acute myeloid leukaemia — n=30, PRR 20.9
- Interstitial lung disease — n=58, PRR 13.0
- Neutropenia — n=150, PRR 12.0
- Hypothyroidism — n=32, PRR 10.9
- Pneumonitis — n=24, PRR 9.6
- Neuropathy peripheral — n=75, PRR 8.6
- Type 2 diabetes mellitus — n=24, PRR 7.7
- Septic shock — n=30, PRR 7.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Vinblastine?
In FDA FAERS, the most frequently co-reported reaction terms for Vinblastine are febrile neutropenia, neutropenia, neuropathy peripheral, pancytopenia, neutrophil count decreased, sepsis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Vinblastine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected.
Do FAERS signals prove that Vinblastine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f073b58e-56d6-4c8d-a2ce-b37719402d77, effective 20250415; matched on
openfda.generic_name.exact:"VINBLASTINE SULFATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 61 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.